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Results from the randomized phase III DREAMM-7 study of belantamab mafodotin (belamaf) + bortezomib, and dexamethasone (BVd) vs daratumumab, bortezomib, and dexamethasone (DVd) in relapsed/refractory multiple myeloma (RRMM).

2024; Lippincott Williams & Wilkins; Volume: 42; Issue: 36_suppl Linguagem: Inglês

10.1200/jco.2024.42.36_suppl.439572

1527-7755

María‐Victoria Mateos, Paweł Robak, Marek Hus, Zhongjun Xia, Vera Zherebtsova, Christopher Ward, P. Joy Ho, Roman Hájek, Kihyun Kım, Meletios Α. Dimopoulos, Claudio Cerchione, Antonio Riccio, Astrid McKeown, Rachel Rogers, Hena Baig, Lydia Eccersley, Sumita Roy–Ghanta, Joanna Opalinska, Vânia Hungria,

Cancer therapeutics and mechanisms

439572 Background: Belamaf, a BCMA-targeted antibody drug conjugate, has previously demonstrated clinical activity and a manageable safety profile, supporting its use in combination with standard-of-care (SoC) therapies in RRMM. DREAMM-7 (NCT04246047) is a global, randomized, open-label, phase III head-to-head trial evaluating the efficacy and safety of BVd triplet vs SoC triplet, DVd, in patients (pts) with RRMM with ≥1 prior line of therapy (LOT). Methods: Pts with ≥1 prior LOT were randomized (1:1) to BVd: B 2.5 mg/kg IV Q3W + V 1.3 mg/m 2 (D1, 4, 8, 11 of 21-day cycles (C); up to 8 C) + d 20 mg (D1, 2, 4, 5, 8, 9, 11, 12; up to 8 C) or DVd: D 16 mg/kg (21-day C), C1-3, Q1W, C4-8, Q3W, and Q4W from C 9 on); V and d schedules were the same. The primary endpoint was independent review committee-assessed progression free survival (PFS). Secondary endpoints available include overall survival (OS), duration of response (DOR), overall response rate (ORR). Results: 494 pts were randomized (BVd n = 243, DVd n = 251). With a median (range) follow-up of 28.2 mo (0.10-40 mo), the median PFS (mPFS) in the BVd arm was 36.6 mo (95% CI, 28.4 mo-NR) vs 13.4 mo (11.1-17.5 mo) with DVd; hazard ratio (HR) 0.41 (95% CI, 0.31-0.53; p < 0.00001). OS data was 29% mature; median OS was not reached in either arm; HR, 0.57 (95% CI, 0.40-0.80; nominal p < 0.0005). ORR was 82.7% (95% CI, 77.4-87.3%) with BVd and 71.3% (65.3-76.8%) with DVd. Median DOR (mDOR) was 35.6 mo (95% CI, 30.5 mo-NR) for BVd vs 17.8 mo (13.8-23.6 mo) for DVd. All pts in both arms experienced ≥1 AE (Table). Grade 3/4 treatment-related AEs (TRAE) were reported in 90% of pts in the BVd arm and 67% with DVd. Serious AEs (SAE) were reported in 50% of pts in BVd vs 37% in DVd arm. Ocular AEs were more frequent on BVd vs DVd (79% vs 29%) and were manageable. Conclusions: The DREAMM-7 head-to-head study of BVd vs DVd demonstrated statistically significant PFS benefit of BVd with a mPFS improvement of 23 mo in pts with RRMM with ≥1 prior LOT. A strong and clinically meaningful OS benefit (nominal p < 0.0005) was observed. Additionally, BVd led to greater depth of response and doubling of mDOR vs DVd and had a manageable safety profile. These results support BVd as a potential new SoC in this setting. Clinical trial information: NCT04246047 . [Table: see text]